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Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly immobilized persons, increasing the burden of care to professionals in the health system, as well as pharmaceutical spending. There are studies of the effectiveness of various products in the prevention of the UPP, most made in hospitals and using fundamentally composed based on oily hyperbecome oxygenated acids (AGHO).
There do not exist studies realized specifically with cream of olive oil.
AIMS:
Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost - efficiency of this new intervention opposite to AGHO's application.
To value the degree of satisfaction of the patient and his keeper with regard to the use of cream of olive oil.
METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil to the group of intervention and AGHO's administration to the group control. Follow-up for one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and clinical data, presence of technical supports, information of the caragiver and questionnaire of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio. Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the increase cost efficiency (ICER). Logistic regression model multivariant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyper-oxigenated fatty acid | Active Comparator | Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum |
|
| Olive oil's Cream | Experimental | Cream with 60% extra virgin olive oil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyper-oxigenated fatty acid | Drug | Aplicación tópica de Mepentol (R) en zonas de riesgo de úlceras por presión (sacro, caderas y talones) 1 aplicación/24 horas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appearance grade II pressure ulcers | The primary outcome or result is the appearance of grade II pressure ulcers in patients under study during the 9 months follow up. This will be confirmed by observation of the areas where we did the intervention (sacrum, hips and heels). | 48 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inmaculada Lupiáñez-Pérez, Enfermera | Distrito Sanitario Málaga. Servicio Andaluz de Salud | Study Chair |
| Leovigildo Ginel-Mendoza, Medico | Distrito Sanitario Málaga. Servicio Andaluz de Salud | Principal Investigator |
| Francisco Javier Navarro-Moya, Enfermero | Distrito Sanitario Málaga. Servicio Andaluz de Salud | Principal Investigator |
| Francisco Javier MartÃn-Santos, Enfermero | Distrito Sanitario Málaga. Servicio Andaluz de Salud | Principal Investigator |
| Rafaela Sepúlveda-Guerra, Enfermera | Distrito Sanitario Málaga. Servicio Andaluz de Salud | Principal Investigator |
| Rosa Vázquez-Cerdeiros, Enfermera | Distrito Sanitario Málaga. Servicio Andaluz de Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Distrito Sanitario Málaga. Servicio Andaluz de Salud | Málaga | Málaga | 29009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28922519 | Derived | Lupianez-Perez I, Morilla-Herrera JC, Kaknani-Uttumchandani S, Lupianez-Perez Y, Cuevas-Fernandez-Gallego M, Martin-Santos F, Caro-Bautista J, Morales-Asencio JM. A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial. Wound Repair Regen. 2017 Sep;25(5):846-851. doi: 10.1111/wrr.12586. Epub 2017 Nov 6. | |
| 25886152 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2013 | |
| Reset | Sep 16, 2013 | |
| Release | Sep 23, 2013 | |
| Unrelease | Yes | |
| Release | Nov 12, 2013 | |
| Unrelease | Yes | |
| Release | Nov 13, 2013 | |
| Reset | Dec 29, 2013 | |
| Release | Jan 15, 2014 | |
| Reset | Mar 3, 2014 | |
| Release | Jan 13, 2015 | |
| Reset | Jan 21, 2015 | |
| Release | Jul 5, 2015 | |
| Reset | Jul 31, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2013 | Sep 16, 2013 | |||
| Sep 23, 2013 |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Olive oil's cream | Other | Application Olive oil's cream to 60% in areas at risk of pressure ulcers (sacrum, hips and heels) 1 application / 24 hours |
|
| Derived |
| Lupianez-Perez I, Uttumchandani SK, Morilla-Herrera JC, Martin-Santos FJ, Fernandez-Gallego MC, Navarro-Moya FJ, Lupianez-Perez Y, Contreras-Fernandez E, Morales-Asencio JM. Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial. PLoS One. 2015 Apr 17;10(4):e0122238. doi: 10.1371/journal.pone.0122238. eCollection 2015. |
| 24152576 | Derived | Lupianez-Perez I, Morilla-Herrera JC, Ginel-Mendoza L, Martin-Santos FJ, Navarro-Moya FJ, Sepulveda-Guerra RP, Vazquez-Cerdeiros R, Cuevas-Fernandez-Gallego M, Benitez-Serrano IM, Lupianez-Perez Y, Morales-Asencio JM. Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial. Trials. 2013 Oct 23;14:348. doi: 10.1186/1745-6215-14-348. |
| Yes |
| Nov 12, 2013 | Yes |
| Nov 13, 2013 | Dec 29, 2013 |
| Jan 15, 2014 | Mar 3, 2014 |
| Jan 13, 2015 | Jan 21, 2015 |
| Jul 5, 2015 | Jul 31, 2015 |